The inspection was conducted from 19 February 2025 to 25 February 2025.
At the conclusion of the inspection, the USFDA issued a Form 483 with three observations. The company stated that these observations are procedural in nature, and it plans to submit corrective and preventive actions to the USFDA within the required time frame.
The company further clarified that the observations are not repeated and are unrelated to any data integrity concerns.
Gland Pharma is one of the largest and fastest-growing injectable-focused companies, with a global footprint across 60 countries, including the United States, Europe, Canada, Australia, India, and other markets. It has a wide range of injectables, including vials, ampoules, pre-filled syringes, lyophilized vials, dry powders, infusions, oncology, and ophthalmic solutions. The company also pioneered Heparin technology in India.
Gland Pharma’s consolidated net profit increased 6.67% to Rs 204.70 crore despite 10.42% decline in revenue from operations to Rs 1,384.1 crore in Q3 FY25 over Q3 FY25.
The scrip rallied 4.62% to settle at Rs 1,595.50 on the BSE.